The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity
Status:
Completed
Trial end date:
2016-10-03
Target enrollment:
Participant gender:
Summary
Functional Dyspepsia-Postprandial Distress Syndrome (FD-PDS), is characterized by
meal-related symptoms such as early satiation and postprandial fullness. Disturbances of
gastric motor function have been implicated the pathogenesis of PDS symptoms, and hence,
motility modifying agents are considered for the treatment of PDS. Prucalopride (Resolor®), a
highly selective 5-TH4 receptor agonist which stimulates gastrointestinal motility throughout
the GI tract, is currently approved for the treatment of chronic constipation. The objective
of this study was to evaluate the effect of prucalopride on gastric sensorimotor function in
healthy volunteers (HV). Methods A total of 17 HV (59% females, mean age 29.4±2.7 years)
underwent a barostat and intragastric pressure (IGP) measurements after treatment with
placebo or prucalopride (2 mg) in a single blinded cross-over fashion. Isobaric distentions
with stepwise increments of 2 mm Hg starting from minimal distending pressure (MDP) and
scoring of intensities of gastric sensations (0-6: pain) were used to determine gastric
compliance and sensitivity. Gastric accommodation (GA) was quantified as the difference
(delta) in intra-balloon volume 30 min before and 60 min after ingestion of 200 ml of a
nutrient drink (ND) (1.5 kcal mL(-1)). GA measured by IGP was quantified as the drop of IGP
from baseline during the intragastric infusion of ND until maximal satiation. During all
tests, epigastric symptoms were scored every 5 minutes.